Of the 23 observations raised by the US Food and Drug Administration during its inspection of Sun Pharmaceutical Industries’ Halol plant in Gujarat, one points out that the company did not have a formalised corrective action plan to address issues that caused recall of two of its drugs in January and July, 2014.

FE examined the 19-page Form 483, or an initial observation report, obtained from the USFDA. The details of the document were first analysed by Credit Suisse experts in a research report dated September 26.

In July, two batches, or 41,127 bottles, of depression drug venlafaxine hydrochloride were voluntarily recalled by Caraco after stability results found the product did not meet the drug release dissolution specifications — the rate at which the active ingredient is released from the dosage in the body did not meet the required standards.

The investigators noted in Form 483 that after the metformin recall, a document dated August 23 containing corrective actions was created, which documents the progress of corrective and preventive actions (CAPA). It said, “All the actions have been implemented hence this report shall be treated as final closure report for (the field alert report). However, complaint file shall remain open till recall is terminated.” However, the document seems to be invalidated by the following observation.

“The deputy manager of Quality Assurance confirmed that there is no ‘CAPA’ or formalised (corrective actions) for the above recall drug product,” the USFDA investigators noted in the Form 483. The exact sentence was repeated in the paragraph which analysed the corrective actions for venlafaxine.

When contacted, Sun Pharma declined to comment on a detailed questionnaire asking comments on various observations noted in Form 483.
The inspection of the injectable unit showed some disrepair, according to the document.

“Building used in manufacturing of a drug product is not maintained in a good state of repair. For example, on September 8, 2014 we observed water stains with ceiling damage and on September 12, 2014 we observed water leaks from the ceiling in the personnel corridor of the Parenteral Manufacturing Area (PMA),” the investigators noted. The PMA is the unit’s injectable production area, according to Credit Suisse.

An inspection of the solid dosage unit shows the operations did not include a challenge test for “foreign particles.” Further, the Form 483 said that Halol unit’s production officer explained that they do not document alarm events that occur during routine tablet compression production.
“The engineer officer and deputy general manager of quality assurance confirmed they do not review or evaluate the alarm conditions/events,” the investigators added.

The Halol facility was inspected for 12 days beginning September 8. The investigation was conducted by three investigators – Parul Patel, Daniel Roberts and Thomas Arista.

Credit Suisse pegs attributes 20-25% of Sun Pharma’s profits to Halol. The company posted a net profit of Rs 3,204 crore for FY2014, an increase of 7% over the previous fiscal.

The letter, dated September 19, was addressed to Vipul Doshi, executive vice president in charge of quality and regulatory affairs.
“There are no data integrity issues on the form; therefore, the chances of an import alert are low. However, there are several procedural issues where resolution could take time and until then, approvals could be blocked (impacting growth, as the fastest growing division is US sales from the Indian plants),” Credit Suisse analysts wrote.